Chronic rhinosinusitis is a common, high-morbidity chronic inflammatory disease, and patients often experience suboptimal outcomes with current medical treatment. The exhalation delivery system with fluticasone (EDS-FLU) may improve care by increasing superior/posterior intranasal corticosteroid deposition.

Researchers conducted this study to evaluate the efficacy and safety of EDS-FLU versus EDS-placebo in patients with NP. Coprimary endpoints were changes in nasal congestion and polyp grade. Critical secondary endpoints were the SNOT-22 and MOS Sleep-R. Other prespecified endpoints included all four cardinal symptoms of NP, 36-Item SF-36, PGIC, RSDI, and essential surgical intervention indicators.

The present study was a randomized, double-blind, EDS-placebo-controlled, multicenter study.

Three hundred twenty-three subjects with NP and moderate-severe congestion/obstruction, most with a history of corticosteroid use and prior surgery, were randomized to EDS-FLU 93 µg, 186 µg, or 372 µg or EDS-placebo twice daily (BID) for 24 weeks.

EDS-FLU produced statistically significant and clinically meaningful improvements in EDS-placebo in multiple subjective and objective outcomes in patients with CRSwNP. They were symptomatic despite high prior intranasal steroid use and surgery, including all four cardinal signs of CRSwNP.